- Bristol Myers Squibb (Trenton, NJ)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director Clinical Site Operations provides strategic oversight, ... leadership and management of clinical trial execution, including oversight of site management...and other applicable federal (FDA) and state regulations. The Associate Director Clinical Site Operations… more
- Taiho Oncology (Princeton, NJ)
- …of timelines, budget, recruitment and country/ site selection strategies, and provision of clinical trial materials. + Serves as main study contact for the ... Associate Director, Clinical Operations Pleasanton, CA,...sites. + Responsible for the financial management of the clinical trial in conjunction with his/her supervisor… more
- ThermoFisher Scientific (Bridgewater, NJ)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... Impactful Work:** Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts...study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC… more
- J&J Family of Companies (Spring House, PA)
- …Physician (MRP) and/or Safety Management Team (SMT). + Reviews and interprets clinical trial data to enable timely internal decision-making and external ... Associate Director, Translational Clinical Medical Lead...+ Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is required. + Ability… more
- J&J Family of Companies (Titusville, NJ)
- …in optimizing our site engagement strategies and facilitating successful clinical trial operations globally. **Key Responsibilities:** + Collaborate closely ... Associate Director, Site Engagement Strategy -...impact to participant health and wellbeing by reinventing the clinical trial experience. The Innovative Health Engagement… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... clinical monitoring and required reporting, including pre-study visits, site invitation visits, routine monitoring visits (both onsite and...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- Merck (Trenton, NJ)
- …and ensures continuity of site relationships through all phases of the trial . + Performs clinical study site management/monitoring activities in ... externally. Acts as primary site contact and site manager throughout all phases of a clinical... site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.… more
- Merck (Trenton, NJ)
- …Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). + Responsible for project management of the ... and escalates performance issues and training needs to CRA ( Clinical Research Associate ) manager and/or functional vendor...country roles ensuring a strong collaboration (including the CTC Clinical Trial Coordinator, CRAs and COM … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and … more
- Hackensack Meridian Health (Neptune, NJ)
- …works under the general supervision of the principal investigator responsible for the clinical trial (s) to which is assigned. **Responsibilities** + Acts as ... on each protocol and each patient participating in a clinical trial protocol in the clinical...SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified … more
- Merck (Trenton, NJ)
- …and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives. Under the guidance of ... and/or functional lines. This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country...line management position. + Deep knowledge and understanding of Clinical Trial processes, GCP and applicable … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely...compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity… more
- Bristol Myers Squibb (Princeton, NJ)
- …the development and implementation of innovative strategies and technologies for clinical trial programming. A ssociate Director develop collaborative ... the development and implementation of innovative strategies and technologies for clinical trial programming + Independently develops, validates, troubleshoots,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and ethical standards + Ensures active participation of FM in providing input on clinical trial site selection and feasibility based on their knowledge ... insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on...in their geography + Ensures FM team's execution of clinical trial support activities (as per established… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Hackensack Meridian Health (Neptune, NJ)
- …contain accurate, complete and up-to-date records of each patient participating in a clinical trial and reviews source documents for completeness. + Provides ... : + SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research… more
- Merck (North Wales, PA)
- …Engineering or related field plus 9 years SAS programming experience in a clinical trial environment. MS in Computer Science, Statistics, Applied Mathematics, ... 7 or more years SAS programming experience in a clinical trial environment. **Department Required Skills and...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck (Trenton, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck (North Wales, PA)
- …years or Master's plus minimum 7 years SAS programming experience in a clinical trial environment + Experience leading large and/or complex statistical ... **Job Description** The Associate Principal Programmer leads the statistical programming activities...compliance and timeliness requirements. + Expertise in SAS and clinical trial programming including data steps, procedures,… more